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Recruiting NCT07422779

Immunotherapy Efficacy and PD-L1 as a Predictive Biomarker in Metastatic Melanoma in Slovenia

No phase Interventional Metastatic Melanoma Skin Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pembrolizumab, Nivolumab, Ipilimumab.
Who it may be relevant to
Registry conditions: Metastatic Melanoma, Skin Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Slovenia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Efficacy of Immunotherapy in the First-Line Treatment of Metastatic Melanoma in Slovenia and Predictive Value of PD-L1 Expression in Tumor and Blood

Overview

The purpose of this study is to evaluate the efficacy of immunotherapy in the first-line treatment of metastatic melanoma in Slovenia and to investigate the association between PD-L1 expression and treatment response. The study aims to determine the relationship between exosomal PD-L1 miRNA expression, PD-L1 expression in tumor tissue, and PD-L1 expression on the surface of immune cells, and response to immunotherapy. The study will also evaluate the association between immune-related adverse events and survival.

Detailed description

This study evaluates the efficacy of immunotherapy in the first-line treatment of metastatic melanoma in Slovenia and investigates the predictive value of PD-L1 expression in tumor tissue and blood. The aim is to assess the association between exosomal PD-L1 miRNA expression, PD-L1 expression in tumor tissue, and PD-L1 expression on the surface of immune cells, and response to treatment with immune checkpoint inhibitors. In addition, the study evaluates the association between the occurrence of immune-related adverse events and survival.

Interventions

  • Drug Pembrolizumab
    PD-1 immune checkpoint inhibitor administered as first-line therapy according to standard clinical practice.
  • Drug Nivolumab
    Nivolumab is a PD-1 immune checkpoint inhibitor administered as first-line systemic immunotherapy for metastatic malignant melanoma according to standard clinical practice, either as monotherapy or in combination with ipilimumab.
  • Drug Ipilimumab
    Ipilimumab is a CTLA-4 immune checkpoint inhibitor administered in combination with nivolumab as first-line systemic immunotherapy for metastatic malignant melanoma according to standard clinical practice.

Primary outcome measures

  • Objective Response Rate (ORR) According to irRECIST [Time frame: Baseline; Week 12 (±2 weeks); Week 28 (±2 weeks)]
Secondary outcome measures (1)
  • PD-L1 Expression in Tumor Tissue (Immunohistochemistry, H-score or % Positive Cells) [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • Age ≥18 years
  • Cytologically or histologically confirmed metastatic malignant melanoma
  • Stage IIID unresectable or stage IV (AJCC 8th edition)
  • ECOG performance status 0-2
  • First-line systemic immunotherapy (pembrolizumab, nivolumab, or ipilimumab/nivolumab)
  • CT/PET-CT performed within 4 weeks prior to treatment start
  • Signed informed consent

Exclusion criteria

  • Previous systemic therapy for melanoma
  • ECOG performance status 3-4
  • Contraindications to immunotherapy (immune deficiency, active immunosuppressive therapy, or active autoimmune disease requiring systemic treatment)
  • Other active malignancy (except cured basal cell carcinoma, squamous cell carcinoma, or other solid tumors without recurrence >3 years)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Slovenia · 1 center
  • Institute of Oncology Ljubljana — Ljubljana

Identifiers

NCT: NCT07422779 · OI-693-MEL-PDL1-2022

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗